Predictive Value of Baseline CTQ-SSS Scores for Progression to Carpal Tunnel Release Surgery: A Cohort Study

Predictive Value of Baseline CTQ-SSS Scores for Progression to Carpal Tunnel Release Surgery: A Prospective Cohort Study

This study aims to determine the predictive value of baseline CTQ-SSS scores for progression to carpal tunnel release (CTR) surgery in patients with carpal tunnel syndrome (CTS). It will be a prospective cohort study involving at least 200 patients with CTS who are undergoing nonsurgical management. Participants will complete the CTQ-SSS and other functional measures at baseline, 3 months, 6 months, and 12 months, and the primary outcome will be progression to CTR surgery. Logistic regression models will be used to assess the predictive value of baseline CTQ-SSS scores for progression to CTR surgery, adjusting for potential confounding factors such as age, sex, and baseline symptom severity. The results of this study can help clinicians identify patients who may benefit from early surgical intervention.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Diagnostic test: CTQ-SSS scores

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with carpal tunnel syndrome who are undergoing nonsurgical management.

Description

Inclusion Criteria:

• Patients with symptoms consistent with carpal tunnel syndrome, such as numbness, tingling, or pain in the hand or wrist.
• Patients with a positive nerve conduction study confirming carpal tunnel syndrome, OR patients with clinical symptoms and signs consistent with carpal tunnel syndrome if a nerve conduction study is not available or inconclusive.
• Patients who have not undergone hand or wrist surgery within the past 6 months.
• Patients who are 18 years of age or older.
• Patients who are willing and able to provide informed consent and comply with study requirements.

Exclusion Criteria:

• Patients with a history of hand or wrist surgery within the past 6 months.
• Patients with severe hand or wrist pain that would prevent completion of the outcome measures or interfere with their ability to participate in the study.
• Patients with severe cognitive impairment or language barrier that would prevent understanding of the study instructions or interfere with their ability to participate in the study.
• Patients with other neurologic or musculoskeletal disorders that could affect hand function or interfere with test completion.
• Pregnant or breastfeeding women.
• Patients who have participated in another clinical trial within the past 30 days.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study Participants; This group will consist of at least 200 patients with carpal tunnel syndrome who are undergoing nonsurgical management. Participants will complete the CTQ-SSS and other functional measures at baseline, 3 months, 6 months, and 12 months. The primary outcome will be progression to carpal tunnel release (CTR) surgery. Logistic regression models will be used to assess the predictive value of baseline CTQ-SSS scores for progression to CTR surgery, adjusting for potential confounding factors such as age, sex, and baseline symptom severity. The results of this study can help clinicians identify patients who may benefit from early surgical intervention.

Diagnostic test: CTQ-SSS scores; The CTQ-SSS is a self-reported questionnaire that measures the severity of symptoms related to carpal tunnel syndrome, including pain, numbness, tingling, and weakness in the hand and wrist. Participants in this study will complete the CTQ-SSS and other functional measures that include: demographic information; hand dominance; Boston Carpal Tunnel Questionnaire (BCTQ); nerve conduction studies (NCS) to measure median nerve conduction velocity (NCV), distal motor latency (DML), and sensory nerve action potential (SNAP) amplitude, Compound muscle action potential (CMAP) amplitude.; Hand grip strength Outcomes will be measured at baseline, 3 months, 6 months, and 12 months. The primary outcome will be progression to carpal tunnel release surgery, and logistic regression models will be used to assess the predictive value of baseline CTQ-SSS scores for this outcome, adjusted for potential confounding factors such as age, sex, and baseline symptom severity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of baseline CTQ-SSS scores for progression to carpal tunnel release (CTR) surgery.	To determine the predictive value of baseline CTQ-SSS scores for progression to CTR surgery in patients with carpal tunnel syndrome undergoing nonsurgical management	Participants will be followed up for a 12-month period.

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): July 12, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 012/0023444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.
• IPD Sharing Access Criteria: via email to mohamed.elmeligie@acu.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No